Influence of Analgesic Technique on Post Operative Rehabilitation After Median Laparotomy: Comparison Between Thoracic Epidural Anesthesia Versus Bilateral Rectus Sheath Block
Led by Centre Hospitalier Régional Metz-Thionville · Updated on 2025-12-16
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2
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26 weeks
Total Duration
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What this Trial Is About
Researchers are evaluating two different locoregional anesthesia techniques to manage postoperative pain and aid recovery after a midline laparotomy, a type of abdominal surgery. This randomized controlled trial compares the commonly used epidural analgesia with a newer method called bilateral rectus sheath block. The study aims to understand how these pain relief methods influence patients' quality of recovery after surgery, measured by the Quality of Recovery-15 score.
Participants are randomly assigned to one of two groups: one receiving thoracic epidural analgesia, where a catheter is placed in the epidural space to deliver local anesthetic, and the other receiving bilateral rectus sheath block under ultrasound guidance, with anesthetic delivered via catheters on both sides of the abdomen. Both groups undergo the same type of abdominal surgery, and the treatments are part of a multimodal pain management approach during and after surgery.
During the study, patients will be monitored for changes in recovery quality on postoperative days 1, 2, and 3, as well as the day before surgery. Assessments include pain control effectiveness, blood pressure effects, nausea, complications related to the analgesic technique, length of hospital stay, bowel function, morphine use, and patient satisfaction up to 30 days after surgery. Catheter placement success, mobility, and other postoperative events are also tracked to understand the impact of each anesthesia method on rehabilitation.
CONDITIONS
Brief Title
Influence of Analgesic Technique on Post Operative Rehabilitation After Median Laparotomy
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
Adults classified as ASA Class I-IV with planned midline laparotomy
Have provided written informed consent
Able to read and understand French
Affiliated with a social security system
You will not qualify if you...
Allergy or contraindication to local anesthetics or epidural analgesia
Conditions like porphyria, hemolytic anemia, uncontrolled epilepsy, severe cardiac conduction disorders
Coagulation disorders, progressive neurological disease, or severe spinal disorder
Inability to place bilateral rectus sheath block
Participation in another clinical study
Pregnant women
Persons deprived of liberty by judicial or administrative decision
Patients under psychiatric care as defined by French Public Health Code
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Day 0 (surgery day) and immediate post-operative period
Participants undergo a midline laparotomy and receive one of two analgesic techniques: thoracic epidural anesthesia or bilateral rectus sheath block for postoperative pain management.
1 surgery visit and several visits during immediate post-operative care
Post-operative Follow-up
Duration - Up to 30 days after surgery
Participants are monitored for recovery, pain management, complications, and quality of recovery using various assessments up to 30 days after surgery.
Visits on postoperative days 1, 2, 3, at hospital discharge, and day 30
Effect of rectus sheath anaesthesia versus thoracic epidural analgesia on postoperative recovery quality after elective open abdominal surgery in a French regional hospital: the study protocol of a randomised controlled QoR-RECT-CATH trial.